- Approval Id
- ba28cbe2a80dbdd7
- Drug Name
- INFANRIX HEXA VACCINE
- Product Name
- INFANRIX HEXA VACCINE
- Approval Number
- SIN12288P
- Approval Date
- 2003-05-07
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION
- Dosage
- <p><strong>Dosage and Administration</strong></p>
<p><strong>Posology</strong></p>
<p>The primary vaccination schedule consists of three doses (of 0.5 mL) which should be administered according to official recommendations (see <em>Pharmacodynamics</em> for schedules evaluated in clinical trials – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). Infanrix hexa can be considered for the booster if the antigen composition is in accordance with the official recommendations.</p>
<img src="/TGIF/InfanrixHexaVaccine-Table1.png" alt="Infanrix Hexa Vaccine Dosage Table 1" /><br><br>
<p>The vaccine may be used to complete a vaccination course initiated with Infanrix-IPV+Hib vaccine.</p>
<p>During the development of the vaccine, the following primary vaccination schedules which are compatible with a policy of administering hepatitis B vaccine at birth were studied in full-term infants: at 2, 3, 4 months of age; at 2, 4, 6 months of age; at 1.5, 3, 5 months of age and at 6, 10, 14 weeks of age.</p>
<p>Additionally, in a study in full-term infants undertaken in Singapore, Infanrix hexa was given as part of a 3, 4, 5 month schedule with Infanrix-IPV+Hib. The Infanrix-IPV+Hib was administered at months 3 and 4 and Infanrix hexa given at month 5. As part of this study, monovalent Hepatitis B vaccine was given at 0 and 1 month in accord with Singapore’s Hepatitis B immunisation policy.</p>
<p>Immunogenicity data for preterm infants was solely obtained in trials that studied 2-4-6 months schedule for primary vaccination. Safety data for preterm infants was also obtained in study Rota-54 that included a greater variety of schedules, i.e. in France (2-3-4 months), Poland (2-3/4-5 months), Spain and Portugal (2-4-6 months).</p>
<p>The Expanded Program on Immunisation schedule (at 6, 10, 14 weeks of age) may only be used if a dose of hepatitis B vaccine has been given at birth.</p>
<p>Where a dose of hepatitis B vaccine is given at birth:</p>
<ul>
<li>Infanrix hexa can be used as a replacement for supplementary doses of hepatitis B vaccine from the age of 6 weeks. If a second dose of hepatitis B vaccine is required before this age, monovalent hepatitis B vaccine should be used.</li>
<li>Infanrix hexa can be used for a mixed immunisation schedule with GSK’s combined pentavalent diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, <em>Haemophilus influenzae</em> type b (DTPa-IPV+Hib) vaccine in accordance with official recommendations.</li>
</ul>
<p>Locally established immunoprophylactic measures against hepatitis B should be maintained.</p>
<p><em>Interchangeability</em></p>
<p>Infanrix hexa can be replaced by the administration of GSK’s pentavalent DTPa-IPV+Hib vaccine co-administered with GSK’s HBV vaccine.</p>
<p><em>Heterologous booster</em></p>
<p>Infanrix hexa may be used as a booster in individuals who have previously been vaccinated with another hexavalent vaccine or pentavalent DTPa-IPV+Hib vaccine associated with a monovalent hepatitis B vaccine.</p>
<p><strong>Method of administration</strong></p>
<p>Infanrix hexa is for deep intramuscular injection.</p>
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- <p><strong>Indications</strong></p>
<p>Infanrix hexa is indicated for primary and booster vaccination of infants and toddlers from the age of 6 weeks against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and <em>Haemophilus influenzae</em> type b.</p>
<p>The use of Infanrix hexa should be in accordance with official recommendations.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p>Hypersensitivity to the active substances or to any of the excipients or residues such as formaldehyde, neomycin and polymyxin (see <em>Qualitative and quantitative composition</em> and <em>List of Excipients</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, polio or Hib vaccines.</p>
<p>Infanrix hexa is contraindicated if the child has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis-containing vaccine. In these circumstances, pertussis vaccination should be discontinued, and the vaccination course should be continued with diphtheria-tetanus, hepatitis B, inactivated polio and Hib vaccines.</p>
- Atc Code
- J07CA09
- Atc Item Name
- diphtheria-haemophilus influenzae B-pertussis-poliomyelitis-tetanus-hepatitis B
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
